ATRIAL FIBRILLATION and Metformin

ATRIAL FIBRILLATION Symptoms and Causes

An arrhythmia is a problem with the speed or rhythm of the heartbeat. Atrialfibrillation (AF) is the most common type of arrhythmia. The cause is a disorder in the heart's electrical system.

Often, people who have AF may not even feel symptoms. But you may feel

Palpitations -- an abnormal rapid heartbeat

Shortness of breath

Weakness or difficulty exercising

Chest pain

Dizziness or fainting

Fatigue

Confusion

AF can lead to an increased risk of stroke. In many patients, it can also cause chest pain, heart attack, or heart failure.

Doctors diagnose AF using family and medical history, a physical exam, and a test called an electrocardiogram (EKG), which looks at the electrical waves your heart makes. Treatments include medicines and procedures to restore normal rhythm.

ATRIAL FIBRILLATION Clinical Trials and Studies

Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses. People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff.

Maximum observed plasma concentration (Cmax) of Saxagliptin; Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of Saxagliptin; Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Saxagliptin; Maximum observed plasma concentration (Cmax) of 5-hydroxy Saxagliptin; Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of 5-hydroxy Saxagliptin; Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of 5-hydroxy Saxagliptin; Maximum observed plasma concentration (Cmax) of Metformin; Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of Metformin; Area under the plasma concentration-time curve from time zero to 12 hours [AUC(0-12)] of Metformin; Safety: based on medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests; Formulation swallowability of Saxagliptin-Metformin FDC tablet, Glucophage® IR tablet and Glucophage® XR tablet

Efficacy, as measured by an improvement in PSA doubling time (PSADT) between baseline and 6 months, of the combination of Metformin plus simvastatin in patients with recurrent prostate cancer following definitive treatment.; Time to protocol-specified event for men treated with the combination of Metformin plus simvastatin.; Pattern of change in log PSA levels and PSA velocity over time during treatment with Metformin plus simvastatin.; Associations between changes in metabolic parameters (fasting glucose/insulin/lipid panel/leptin/adiponectin and others) with the pattern of change in log PSA levels.

Change From Baseline to Week 26 (or Early Termination) in Glycosylated Hemoglobin (HbA1c); Change From Baseline in HbA1c Over Time; Change From Baseline in Fasting Plasma Glucose Over Time; Time to hyperglycemic rescue event; Percentage of Participants Meeting Rescue Criteria; Percentage of Participants With Marked Hyperglycemia; Change From Baseline in Body Weight Over Time; Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5%; Percentage of Participants With Glycosylated Hemoglobin ≤ 7.0%; Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5%; Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5%; Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.0%; Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5%; Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2.0%

Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours (AUC0-72); Maximum measured concentration of linagliptin in plasma (Cmax); Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz); Cmax of Metformin in plasma; Area under the concentration-time curve of linagliptin and Metformin in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf); AUC0-inf of Metformin in plasma

Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours (AUC0-72); Maximum measured concentration of linagliptin in plasma (Cmax); Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz); Cmax of Metformin in plasma; Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf); AUC0-inf of Metformin in plasma

Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours (AUC0-72); Maximum measured concentration of linagliptin in plasma (Cmax); Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz); Cmax of Metformin in plasma; Area under the concentration-time curve of Metformin in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf); AUC0-inf of linagliptin in plasma

AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) for BI 187004; AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) for Metformin; Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) for BI 187004; Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) for Metformin

change from baseline in breast density at 6 and 12 months; change from baseline in serum insulin levels at 6 and 12 months; change from baseline in serum IGF-1 to IGFBP-3 ratio at 6 and 12 months; change from baseline in serum testosterone levels at 6 and 12 months; change from baseline in serum leptin to adiponectin ratio at 6 and 12 months; change from baseline in body weight at 6 and 12 months; change from baseline in waist circumference at 6 and 12 months; change from baseline in serum IGF-2 levels at 6 and 12 months

If you think you may have a medical emergency, call your doctor or 911 immediately.

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